MAUDE Adverse Event Report: GE MEDICAL SYSTEMS, LLC GE INNOVA 3100; INTERVENTIONAL FLUOROSCOPIC X-RAY SYSTEM

Model Number 3100

Device Problems Device Stops Intermittently (1599); Device Operates Differently Than Expected (2913)

Patient Problem No Information (3190)

Event Date 10/27/2016

Event Type  malfunction  

Event Description

Ge innova x-ray went down during procedure.No harm to patient.The patient was moved to another room and the procedure was completed.During the procedure, the system would lock up and not make exposures.When staff would re-boot the system, it would shut itself off.

• Brand Name: GE INNOVA 3100
• Type of Device: INTERVENTIONAL FLUOROSCOPIC X-RAY SYSTEM
• Manufacturer (Section D): GE MEDICAL SYSTEMS, LLC; 3000 north grandview blvd.; waukesha WI 53188
• MDR Report Key: 6098853
• MDR Text Key: 59744255
• Report Number: 6098853
• Device Sequence Number: 1
• Product Code: IZI
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: User Facility
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 11/08/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: No Information
• Device Model Number: 3100
• Was Device Available for Evaluation?: Yes
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 11/08/2016
• Event Location: Hospital
• Date Report to Manufacturer: 11/08/2016
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 11/14/2016
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Age: 79 YR